NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
- Conditions
- Non-Small Cell Lung CancerNFE2L2 Gene MutationKEAP1 Gene MutationNRF2 MutationNon-Squamous Non-Small Cell Neoplasm of LungNon-squamous Non-small-cell Lung Cancer
- Registration Number
- NCT04698681
- Lead Sponsor
- Calithera Biosciences, Inc
- Brief Summary
This is a multicenter screening protocol designed to identify patients with NSCLC who have tumor mutations in the KEAP1 or NRF2/NFE2L2 genes in order to determine potential eligibility for a biomarker selected clinical trial (CX-839-014, otherwise known as the KEAPSAKE trial). Circulating tumor DNA (ctDNA) present in blood samples collected from eligible patients will be analyzed by next generation sequencing (NGS) for selected biomarkers. A commercial liquid biopsy NGS test will be provided to study participants free of charge.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
Patients with stage IV non-squamous non-small-cell lung cancer (NSCLC) who have not been previously treated with systemic therapy for metastatic disease, and meet all of the following:
- Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable).
- Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age ≥ 18 years old on the day of signing informed consent.
- Estimated life expectancy > 3 months.
- At least one radiographically measurable lesion per RECIST v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI).
- Clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + Pembrolizumab (PCP) for stage IV disease.
Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA Up to 16 months The percentage of patients with nonsquamous NSCLC containing pathogenic NRF2/NFE2L2 and/or KEAP1 mutations
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
Southern Cancer Center
🇺🇸Daphne, Alabama, United States
Arizona Oncology Associates - Glendale
🇺🇸Glendale, Arizona, United States
Rocky Mountain Cancer Centers - Lakewood
🇺🇸Lakewood, Colorado, United States
Arizona Oncology Associates
🇺🇸Scottsdale, Arizona, United States
Rocky Mountain Cancer Centers - Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers - Aurora
🇺🇸Aurora, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
🇺🇸Centennial, Colorado, United States
Maryland Hematology Oncology - Silver Spring
🇺🇸Silver Spring, Maryland, United States
Medical Oncology Hematology Consultants
🇺🇸Newark, Delaware, United States
Rocky Mountain Cancer Centers - Boulder
🇺🇸Boulder, Colorado, United States
Woodlands Medical Specialists
🇺🇸Pensacola, Florida, United States
Rocky Mountain Cancer Centers - Lone Tree
🇺🇸Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers - Littleton
🇺🇸Littleton, Colorado, United States
Rocky Mountain Cancer Centers - Thornton
🇺🇸Thornton, Colorado, United States
Maryland Oncology Hematology - Bethesda
🇺🇸Bethesda, Maryland, United States
Maryland Oncology Hematology - Brandywine
🇺🇸Brandywine, Maryland, United States
Maryland Oncology Hematology - Clinton
🇺🇸Clinton, Maryland, United States
Maryland Oncology Hematology - Lanham
🇺🇸Lanham, Maryland, United States
Maryland Hematology Oncology - Frederick
🇺🇸Frederick, Maryland, United States
Maryland Hematology Oncology - Rockville
🇺🇸Rockville, Maryland, United States
Oncology Hematology Care - Fairfield
🇺🇸Fairfield, Ohio, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
Texas Oncology - West Texas Amarillo
🇺🇸Amarillo, Texas, United States
Consultants in Medical Oncology and Hematology
🇺🇸Wynnewood, Pennsylvania, United States
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Texas Oncology Cancer Care and Research
🇺🇸Harlingen, Texas, United States
Virginia Oncology Associaties
🇺🇸Chesapeake, Virginia, United States
Texas Oncology - Beaumont
🇺🇸Beaumont, Texas, United States
Texas Oncology - Carrollton
🇺🇸Carrollton, Texas, United States
Texas Oncology - Weslaco
🇺🇸Weslaco, Texas, United States
Texas Oncology - Denton
🇺🇸Denton, Texas, United States
Texas Oncology - Flower Mound
🇺🇸Flower Mound, Texas, United States
Texas Oncology - Longview Cancer Center
🇺🇸Longview, Texas, United States
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
Texas Oncology - Tyler
🇺🇸Tyler, Texas, United States
Texas Oncology - West Texas Midland
🇺🇸Midland, Texas, United States
Texas Oncology - West Texas Odessa
🇺🇸Odessa, Texas, United States
Texas Oncology - Sherman
🇺🇸Sherman, Texas, United States
Texas Oncology - West Texas Wichita Falls
🇺🇸Wichita Falls, Texas, United States
Virginia Cancer Specialists
🇺🇸Norfolk, Virginia, United States
Southern Cancer Center - 3 Mobile Infirmary Circle
🇺🇸Mobile, Alabama, United States
Virginia Oncology Associates
🇺🇸Virginia Beach, Virginia, United States
Southern Cancer Center - Dauphin St
🇺🇸Mobile, Alabama, United States
Rocky Mountain Cancer Centers - Englewood
🇺🇸Englewood, Colorado, United States
Southern Cancer Center - Providence Hospital
🇺🇸Mobile, Alabama, United States
Arizona Oncology Associates - Tempe
🇺🇸Tempe, Arizona, United States
Rocky Mountain Cancer Centers - Longmont
🇺🇸Longmont, Colorado, United States
Rocky Mountain Cancer Centers - Pueblo
🇺🇸Pueblo, Colorado, United States
Maryland Oncology Hematology
🇺🇸Columbia, Maryland, United States
Arizona Oncology Associates - E. Highland Ave.
🇺🇸Phoenix, Arizona, United States
Arizona Oncology Associates - N. 27th Ave.
🇺🇸Phoenix, Arizona, United States
Oncology Hematology Care - Mercy Health Blvd
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care - Malsbary Rd
🇺🇸Cincinnati, Ohio, United States
Oncology Hematology Care - Ivy Gateway
🇺🇸Cincinnati, Ohio, United States
Rocky Mountain Cancer Centers - Williams Street
🇺🇸Denver, Colorado, United States
Rocky Mountain Cancer Centers - E. Hale Parkway
🇺🇸Denver, Colorado, United States
Northwest Cancer Specialists - NE Hoyt St
🇺🇸Portland, Oregon, United States
Northwest Cancer Specialists - N. Broadway
🇺🇸Portland, Oregon, United States